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Does Patent Foramen Ovale Size Matter in Men and Women

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ClinicalTrials.gov Identifier: NCT03904277
Recruitment Status : Recruiting
First Posted : April 5, 2019
Last Update Posted : April 28, 2021
Sponsor:
Information provided by (Responsible Party):
University of Oregon

Study Description
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Brief Summary:
A patent foramen ovale (PFO) is present in ~30% of the general population. The PFO has historically been considered to be trivial. However, recent work by the investigator's group and others has identified that, compared to individuals without a PFO, those with a PFO have worse pulmonary gas exchange efficiency, have a higher core body temperature, blunted ventilatory responses to chronic hypoxia and acute carbon dioxide and increased susceptibility to altitude illnesses such as acute mountain sickness, and high altitude pulmonary edema (Lovering, Elliott & Davis J Appl Physiol 2016). Specific to this application,subjects with a PFO may have worse pulmonary gas exchange efficiency because a PFO is a potential source of right-to-left shunt that will make pulmonary gas exchange efficiency worse. If true, then this may negatively impact exercise capacity and/or exercise tolerance. Further, in those with a PFO compared to those without, preliminary work from the investigator's lab indicates that there may be an effect of PFO size on pulmonary gas exchange efficiency. This is such that those with a large PFO (grade 3 or higher) display significantly worse gas exchange efficiency compared to those with a small (grade 2 or lower) or no PFO,even at low exercise workloads. Additionally, the investigators were curious as to whether there would be a sex effect, but due to logistical constraints, the investigators were unable to recruit an equal number of female and male subjects. Thus, in addition to the potential size effect on the investigators outcome measures, the investigators would like to build on this work by examining the potential effect of biological sex. Although a PFO has been traditionally considered to have a minimal impact of physiology and pathophysiology, emerging evidence suggests this may not be the case. The investigator's lab is focused on understanding how and why a relatively small hole in the heart (PFO) can have a relatively large impact on cardiopulmonary and respiratory physiology, and how these impacts may be based on the size of the PFO.

Condition or disease
Patent Foramen Ovale

Study Design
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Study Type : Observational
Estimated Enrollment : 28 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Does Patent Foramen Ovale Size Matter in Men and Women
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021
Groups and Cohorts
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Group/Cohort
No PFO
Research subjects who present no evidence of PFO - IE no appearance of saline contrast microbubbles within 3 cardiac cycles
Small PFO
Research subjects who present evidence of having a small PFO or ASD - IE appearance of 1-11 saline contrast microbubbles within 3 cardiac cycles
Large PFO
Research subjects who present evidence of having a large PFO - IE appearance of 12+ saline contrast microbubbles within 3 cardiac cycles.


Outcome Measures
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Primary Outcome Measures :
  1. alveolar-arterial difference in oxygen [ Time Frame: Baseline ]
    difference in the partial pressure of oxygen between the alveoli (calculated) and arterial blood (direct measure)

  2. aerobic exercise capacity [ Time Frame: Baseline ]
    ability to utilize oxygen while exercising, AKA Vo2MAX

  3. six-minute walk test [ Time Frame: Baseline ]
    distance covered in 6 minutes of walking

  4. minute flow of intrapulmonary areterio-venous anastamoses (QIPAVA) [ Time Frame: Baseline ]
    minute flow through intrapulmonary arteriovenous anastamoses

  5. core body temperature [ Time Frame: Baseline ]
    subject's core body temperature as measured through an ingestible pill

  6. level of tumor necrosis factor alpha [ Time Frame: Baseline ]
    inflammatory marker

  7. level of C-C motif cytokine 2 [ Time Frame: Baseline ]
    inflammatory marker

  8. level of interferon alpha 2 [ Time Frame: Baseline ]
    inflammatory marker

  9. level of interferon gamma [ Time Frame: Baseline ]
    inflammatory marker

  10. level of interleukin 1 beta [ Time Frame: Baseline ]
    inflammatory marker

  11. level of interleukin 6 [ Time Frame: Baseline ]
    inflammatory marker

  12. level of interleukin 8 [ Time Frame: Baseline ]
    inflammatory marker

  13. level of interleukin 10 [ Time Frame: Baseline ]
    inflammatory marker

  14. level of interleukin 12p70 [ Time Frame: Baseline ]
    inflammatory marker

  15. level of interleukin 17 alpha [ Time Frame: Baseline ]
    inflammatory marker

  16. level of interleukin 18 [ Time Frame: Baseline ]
    inflammatory marker

  17. level of interleukin 23 [ Time Frame: Baseline ]
    inflammatory marker

  18. level of interleukin 33 [ Time Frame: Baseline ]
    inflammatory marker

  19. level of myoglobin [ Time Frame: Baseline ]
    inflammatory marker

  20. level of myeloid-related protein 8/14 [ Time Frame: Baseline ]
    inflammatory marker

  21. level of neutrophil gelatinase-associated lipocalin [ Time Frame: Baseline and 3 months post percutaneous closure ]
    inflammatory marker

  22. level of c-reactive protein [ Time Frame: Baseline ]
    inflammatory marker

  23. matrix metallopeptidase 2 [ Time Frame: Baseline and 3 months post percutaneous closure ]
    inflammatory marker

  24. level of osteopontin [ Time Frame: Baseline ]
    inflammatory marker

  25. level of myloperoxidase [ Time Frame: Baseline ]
    inflammatory marker

  26. level of Serum amyloid A [ Time Frame: Baseline ]
    inflammatory marker

  27. level of insulin like growth factor binding protein 4 [ Time Frame: Baseline ]
    inflammatory marker

  28. level of intracellular adhesion molecule 1 [ Time Frame: Baseline ]
    inflammatory marker

  29. level of vascular cell adhesion protein 1 [ Time Frame: Baseline ]
    inflammatory marker

  30. level of metallopeptidase 9 [ Time Frame: Baseline ]
    inflammatory marker

  31. level of Cystatin C [ Time Frame: Baseline ]
    inflammatory marker


Biospecimen Retention:   Samples Without DNA
Plasma from venous blood sample

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Healthy adults aged 18-40 with and without a PFO.
Criteria

Inclusion Criteria:

  • Men and women aged 18-40
  • Known to have/not have a PFO.

Exclusion Criteria:

  • Previous history of coronary artery disease(ischemic heart disease such as angina, heart attack, myocardial infarction).
  • Failure of Modified Allen's Test in both hands.
  • Currently taking medications or herbal supplements for any heart or respiratory disease that they cannot stop taking for 48 hrsprior to testing (seasonal allergy medication not included in exclusion medications).
  • Lidocaine, nitroglycerine or heparin allergy.
  • Women who are pregnant or trying to become pregnant.
  • Previous history of any condition that would prevent the subject from performing cycle ergometer exercise (for exercise study only).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03904277


Contacts
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Contact: Andrew Lovering, PhD 541-346-0831 lovering@uorgeon.edu

Locations
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United States, Oregon
Cardiorespiratory and Pulmonary Physiology Lab Recruiting
Eugene, Oregon, United States, 97403
Contact: Andrew Lovering, PhD    541-346-0831    lovering@uoregon.edu   
Sponsors and Collaborators
University of Oregon
  Study Documents (Full-Text)

Documents provided by University of Oregon:
Study Protocol and Statistical Analysis Plan  [PDF] December 12, 2018

More Information
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Responsible Party: University of Oregon
ClinicalTrials.gov Identifier: NCT03904277    
Other Study ID Numbers: 04302018.049
First Posted: April 5, 2019    Key Record Dates
Last Update Posted: April 28, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Foramen Ovale, Patent
Heart Septal Defects, Atrial
Heart Septal Defects
Heart Defects, Congenital
 Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities